Silvia Quadrini

Combination of aprepitant, palonosetron and dexamethasone as antiemetic prophylaxis in lung cancer patients receiving multiple cycles of cisplatin-based chemotherapy

Introduction:  With repeated courses of chemotherapy, chemotherapy‐induced nausea and vomiting (CINV) becomes progressively more difficult to control. The aim of this study was to evaluate whether the antiemetic efficacy of the triple combination aprepitant, palonosetron and dexamethasone could be sustained for up to six cycles of highly emetogenic chemotherapy (HEC) (cisplatin ≥ 50 mg/m2).

Prevalence of malnutrition in patients at first medical oncology visit: the PreMiO study

Background In cancer patients, malnutrition is associated with treatment toxicity, complications, reduced physical functioning, and decreased survival. The Prevalence of Malnutrition in Oncology (PreMiO) study identified malnutrition or its risk among cancer patients making their first medical oncology visit. Innovatively, oncologists, not nutritionists, evaluated the nutritional status of the patients in this study. Methods PreMiO was a prospective, observational study conducted at 22 medical oncology centers across Italy. For inclusion, adult patients (>18 years) had a solid tumor diagnosis, were treatment-naive, and had a life expectancy >3 months. Malnutrition was identified by the Mini Nutritional Assessment (MNA), appetite status with a visual analog scale (VAS), and appetite loss with a modified version of Anorexia-Cachexia Subscale (AC/S-12) of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT). Findings Of patients enrolled (N=1,952), 51% had nutritional impairment; 9% were overtly malnourished, and 43% were at risk for malnutrition. Severity of malnutrition was positively correlated with the stage of cancer. Over 40% of patients were experiencing anorexia, as reported in the VAS and FAACT questionnaire. During the prior six months, 64% of patients lost weight (1–10 kg). Interpretation Malnutrition, anorexia, and weight loss are common in cancer patients, even at their first visit to a medical oncology center.

Capecitabine in elderly patients with metastatic breast cancer

AIMS AND BACKGROUND Capecitabine is the reference treatment for anthracycline- and/or taxane-pretreated metastatic breast cancer (MBC). This study examined its efficacy, tolerability and impact on the quality of life of elderly patients with MBC. MATERIALS AND METHODS Between January 2002 and December 2009, 75 consecutive elderly patients with MBC received first-line chemotherapy with capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks. Endpoints were efficacy, tolerability and clinical-benefit response measured every 3 cycles. RESULTS Median age was 76 years (range 65-88); median ECOG performance status was 1 (range 0-2); 51 patients (68%) had received adjuvant chemotherapy and all patients had received hormonal therapy. Median exposure was 6 cycles. After 3 cycles, 11 patients (14.7%) had a partial response, one patient experienced a complete response, and 49 patients (65.3%) had stable disease, amounting to a disease control rate of 81.3%. Stable disease was maintained in 45 patients (60%) after 6 cycles, in 21 patients (28%) after 9 cycles, and in 13 patients (17.3%) after 12 cycles. A clinical-benefit response was experienced by 42 patients (56%), indicating a positive impact on quality of life. Treatment was well tolerated, the most common grade 3 events being diarrhea (12%) hand-foot syndrome (8%), and mucositis (8%). Adverse events were managed with dose adjustments and supportive therapy when required. CONCLUSIONS Our results indicate that capecitabine is active and well tolerated in elderly patients with MBC. This dosing regimen warrants further study in the first-line setting for patients with less aggressive MBC who are not candidates for combination therapy.

Italian Nivolumab Expanded Access Program in Nonsquamous Non–Small Cell Lung Cancer Patients: Results in Never-Smokers and EGFR-Mutant Patients

Introduction: Nivolumab is the first checkpoint inhibitor approved for the treatment of nonsquamous NSCLC. We report results from the nivolumab Italian expanded access program focusing on never‐smokers and patients with EGFR‐mutant nonsqamous NSCLC. Methods: Nivolumab (3 mg/kg intravenously every 2 weeks) was administered upon physicians’ request to patients who had relapsed after one or more prior systemic treatments for stage IIIB/IV nonsquamous NSCLC. Efficacy and safety were evaluated in patients who received at least one dose of nivolumab. Results: Of 1588 patients with nonsquamous NSCLC, 305 (19.2%) were never‐smokers. EGFR status was available for 1395 patients. Of the 102 patients (6.4%) with EGFR mutation–positive tumors, 51 (50%) were never‐smokers. The objective response rate was significantly higher in patients with wild‐type EGFR than patients with EGFR‐mutant tumors (19.6% versus 8.8% [p = 0.007]), in former and current smokers than in never‐smokers (21.5% versus 9.2% [p = 0.0001]), and in never‐smokers with wild‐type EGFR than in never‐smokers with mutant EGFR (11.0% versus 1.9% [p = 0.04]). There was no significant difference in objective response rate between smokers with wild‐type EGFR and smokers with mutant EGFR (22.0% versus 20.6%). There was no statistically significant difference in median progression‐free survival or in median overall survival. The median overall survival times were 11 months in patients with EGFR wild‐type tumors versus 8.3 months in patients with EGFR‐mutant tumors, 11.6 months in smokers versus 10.0 months in never‐smokers, 11.0 months in never‐smokers with EGFR wild‐type tumors versus 5.6 months in never‐smokers with EGFR‐mutant tumors, and 14.1 months in smokers with EGFR‐mutant tumors versus 11.3 months in smokers with EGFR wild‐type tumors. Conclusions: The data on the Italian expanded access program in populations with nonsquamous NSCLC suggest that subgroups of patients could benefit differently from nivolumab according to their EGFR mutational status and smoking habits. These results warrant further investigation.

Safety and efficacy of oral vinorelbine and capecitabine combination for metastatic breast cancer

Abstract The aim of this prospective open-label study was to evaluate the efficacy and safety of oral vinorelbine in combination with capecitabine in patients with metastatic breast cancer (MBC). 51 patients with MBC received oral vinorelbine and capecitabine. the safety profile was analyzed through NCI-CTCAE v3.0 and response was evaluated using RECIST criteria. The overall response rate was 37.2%: there were four complete responders (8%) and fifteen partial responders (29.4%); practically all the responders were patients previously treated with anthracyclines and taxanes. Sixteen patients (31.3%) experienced stable disease. the clinical benefit rate was 68.5%. The median time to progression was 8 months (range 2-43; 95% CI: 6-10.8). Vinorelbine in combination with capecitabine is an effective and safe schedule for patients with MBC especially after pretreatment with anthracycline/taxane-based regimens. The clinical benefit suggests that this may be a promising schedule in the MBC initial treatment.

Abiraterone acetate in metastatic castration-resistant prostate cancer after chemotherapy: A “real life” retrospective analysis of progression-free (PFS) and overall survival (OS) according to duration of androgen deprivation therapy.

337 Background: Abiraterone acetate (AA) is a potent, selective androgen (CYP17) biosynthesis inhibitor, which showed to improve overall survival in mCRPC pts progressing after docetaxel. Few data are available concerning the clinical outcome of AA treatment in mCRPC in terms of the duration of prior androgen deprivation therapy (ADT). In this retrospective analysis we assessed the PFS and OS in patients affected with mCRPC according to the duration of ADT. Methods: We retrospectively reviewed the clinical data of pts affected by mCRCP progressive after chemotherapy who received AA (1000 mg/d) plus prednisone (5 mg/twice daily). A total of 189 pts were included in the analysis, 71 received AA with ADT duration<12 months (Group A) and 118 received AA with ADT duration ≥ 12 months (Group B). Patient characteristics’ in the two treatment groups (A VS B) were: median age: 75 vs 69 years, Gleason score ≥7: 96% vs 92%; median PSA at AA start 47 (range 36-2130) vs 32 (range 85-2100), No of metastatic sites: 1 : ...

2544 Abiraterone acetate in metastatic castration-resistant prostate cancer after chemotherapy. A retrospective “Real Life” analysis of activity and safety

androgen (CYP17) biosynthesis inhibitor, which showed to improve overall survival (HR = 0.646) in mCRPC patients progressing after docetaxel. In this retrospective analysis we assessed the safety and efficacy of AA in patients affected with mCRPC progressing after chemotherapy, treated in the routinary clinical practice, in several Italian Oncologic Units, after the approval of the drug from the Italian Drug Agency (AIFA).

What caused gastrointestinal bleeding in a woman with a history of pleural mesothelioma? Metastatic diffuse epithelioid mesothelioma.

A 72-year-old white woman was admitted to the university hospital with malaria. Her medical history highlighted a pleural mesothelioma diagnosed 2 years earlier and treated by left thoracotomy with chest wall and diaphragm resection followed by four courses of …